FDA to approve gastric band for adolescents by 2009

October 1, 2007—Waltham, Massachusetts—Millennium Research Group forecasts that the gastric band market, currently valued at over $190 million, will exceed $630 million by 2012. The expected 2009 FDA approval of the LAP-BAND device for adolescents aged 14 to 18 will significantly expand the potential patient base into one of the most rapidly growing segments of the obese population, according to Millennium Research Group’s US Markets for Laparoscopic Devices 2008 report.

The two surgical approaches to obesity, laparoscopic adjustable gastric banding (LAGB)—which uses devices such as Allergan’s LAP-BAND—and gastric bypass surgery, primarily involve restricting food intake into the stomach, thereby limiting caloric intake. A LAGB procedure involves the placement of an adjustable gastric band around the upper part of the stomach, while gastric bypass surgery changes the anatomy of the digestive system to limit the amount of food that can be eaten and digested. Gastric bypass surgery may currently be performed on adolescents because it does not need FDA approval. Promoters of LAGB point to lower risk of life-threatening complications, adjustability, and reversibility which will encourage further penetration of LAGB procedures among adolescent patients.

“There has been an alarming growth in the number of obese adolescents in the US,” says Barbara Prud’homme, Senior Analyst at MRG. “The approval of the LAP-BAND for adolescents will provide an additional option to treat these younger patients. The FDA stamp of approval of the LAP-BAND will likely make LAGB performed at an increasing rate by doctors.”

The US Markets for Laparoscopic Devices 2008 report includes coverage of industry competitors including Allergan, Ethicon Endo-Surgery, Covidien, Stryker, Applied Medical, and Karl Storz.